Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Post-operative Scarring - Erythema
研究概览
简要总结
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
详细描述
Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.
During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.
The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.
排除标准
- •Had prior eyelid surgery
- •Undergoing additional upper eyelid surgery
- •Using topical treatments on the upper eyelids that would interfere with the investigation
研究组 & 干预措施
All patients
Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel.
干预措施: silicone gel (Device)
结局指标
主要结局
Post-operative Scarring - Erythema
时间窗: Up to 6 months post-operation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.
Post-operative Scarring - Elevation
时间窗: Up to 6 months post-operation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (\<0.5 mm)", and "3=definite elevation (\>0.5 mm)". Higher mean scores are associated with increased elevation.
Post-operative Scarring - Pigmentation
时间窗: 6 months post-operation
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively.
次要结局
- Patient Satisfaction(Up to 6 months post-operation)
- Post-operative Itching(Up to 6 months post-operation)
- Post-Operative Pain(Up to 6 months post-operation)
- Patient Scar Preference(6 months post-operation)